Bipolar, ManiaPhase 4UtapManiNCT01043679
Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania
A Phase 4 study testing Utapine and Seroquel in people with Bipolar, Mania and Utapine, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar, Mania, Utapine, Seroquel
- What is being tested?
- Utapine and Seroquel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2009to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age 18-65 years with diagnosis of bipolar I disorder who will be included by DSM-IV criteria made at least one manic or mixepisode record before study entry.
- Having a minimum score of 20 on the Young Mania Rating Scale (YMRS), plus a score of at least 4 on two of the core YMRS items of Irritability,Speech, Content, and Disruptive/Aggressive Behavior.
- At least 4 will be on the Severity of Illness item of the Clinical Global ImpressionsNBipolar(CGINBP)assessment tool.
- Patient with good compliance to study medicine and adherence to study protocol.
Who cannot join
- Had received treatment with clozapine within 28 days of the start of the trial.
- Had been hospitalised for 3 weeks or longer for the index manic episode.
- DSM-IV criteria for rapid cycling or a current mixed episode.
- Intolerance or lack of response to quetiapine or clozapine before this trial be diagnosed by investigator.
- Neurodegenerative disease eg:Parkinson desease、Huntington disease、Pick's disease.
- Medicine or drugs which can change mental condition be judged by investigator.
- EKG abnormality
- Drug or alcohol abuser
Trial locations and contacts
1 site in 1 country.
Chin-Hong Chan, MD., MS. contact
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Chin-Hong Chan, MD., MS., 886-4-23592525 ext. 3407
Tso-Hung Lan, MD.,PhD., 886-4-23592525 ext. 3460, tosafish@hotmail.com
About this study
Official title: A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania
The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.
Read the detailed description
Utapine and Serquel belong to anti-bipolar medication family, both are approved by DOH (Department of Health, Taiwan), both has same ingredient but different manufacture. From clinical trial reports, both has excellent effectiveness and safety. The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients for different ingredient and different manufacture.
- Conditions
- Bipolar, Mania, Utapine, Seroquel
- Being tested
- Utapine, Seroquel
- Keywords
- Bipolar, Mania, Utapine, Seroquel
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UtapineDrug
Efficacy and Safety of Utapine
SeroquelDrug
Efficacy and Safety of Seroquel
| Study group | Role | What they receive |
|---|---|---|
| Seroquel | Active comparator | Efficacy and Safety of Seroquel Receives: Drug: Seroquel |
| Utapine | Active comparator | Efficacy and Safety of Utapine Receives: Drug: Utapine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar, ManiaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chin-Hong Chan, MD.,MS., Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043679
- Sponsor's protocol ID
- 01122009/S09070
- Acronym
- UtapMani
- Status last verified
- Jan 2010
- First submitted
- 6 Jan 2010
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania
- ClinicalTrials.gov ID
- NCT01043679
- Acronym / sponsor ID
- UtapMani / 01122009/S09070
- Conditions
- Bipolar, Mania, Utapine, Seroquel
- Keywords
- Bipolar, Mania, Utapine, Seroquel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.
Detailed description
Utapine and Serquel belong to anti-bipolar medication family, both are approved by DOH (Department of Health, Taiwan), both has same ingredient but different manufacture. From clinical trial reports, both has excellent effectiveness and safety. The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients for different ingredient and different manufacture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seroquel | Active comparator | Drug: SeroquelEfficacy and Safety of Seroquel |
| Utapine | Active comparator | Drug: UtapineEfficacy and Safety of Utapine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female age 18-65 years with diagnosis of bipolar I disorder who will be included by DSM-IV criteria made at least one manic or mixepisode record before study entry.
- Having a minimum score of 20 on the Young Mania Rating Scale (YMRS), plus a score of at least 4 on two of the core YMRS items of Irritability,Speech, Content, and Disruptive/Aggressive Behavior.
- At least 4 will be on the Severity of Illness item of the Clinical Global ImpressionsNBipolar(CGINBP)assessment tool.
- Patient with good compliance to study medicine and adherence to study protocol.
Key exclusion criteria (8 listed)
- Had received treatment with clozapine within 28 days of the start of the trial.
- Had been hospitalised for 3 weeks or longer for the index manic episode.
- DSM-IV criteria for rapid cycling or a current mixed episode.
- Intolerance or lack of response to quetiapine or clozapine before this trial be diagnosed by investigator.
- Neurodegenerative disease eg:Parkinson desease、Huntington disease、Pick's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UtapineEfficacy and Safety of Utapine | Drug | Utapine |
| SeroquelEfficacy and Safety of Seroquel | Drug | Seroquel |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Hong Chan, MD., MS. contact
Chin-Hong Chan, MD.,MS. principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Utapine and Seroquel in people with Bipolar, Mania and Utapine, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Hong Chan, MD., MS. (886-4-23592525 ext. 3407), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2010.